Shiley 80XLTCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 20884522028179), received between Nov 14, 2018 and Jul 15, 2026 — classified as 2 deaths, 9 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A TRACHEOSTOMY TUBE WAS INSERTED AND APPROXIMATELY 24 HOURS LATER, DETACHMENT OF THE CUFF FIXATION POINT WAS OBSERVED AFTER THE CUFF SYSTEM WAS HANDLED FOLLOWING A SPEECH-LANGUAGE PATHOLOGY EVALUATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 25830323 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE 6 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912902 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE 6 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912870 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, 2 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). BOTH TUBE WERE REPLACED FROM A PATIENT. WHILE THE OTHER 4 HAD SIMILAR ISSUE OBSERVED ON THE SAME DAY DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912761 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE 6 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912706 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE 6 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 20912694 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE 6 TRACHEOSTOMY TUBE'S PILOT BALLOONS DID NOT INDICATED THE AMOUNT OF AIR IN THE CUFF. WHEN AIR WAS ADDED TO CUFF, PILOT BALLOON PRESENTS FLAT (AS IF THERE WAS NO AIR IN THE CUFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 20912617 ↗
• MalfunctionNov 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION VALVE AND GUIDE TUBE (INFLATION LINE) WAS DISCONNECTED AS SHOWN IN THE IMAGE ATTACHED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18151846 ↗
• MalfunctionNov 9, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE DID NOT FIT THE OTHER BRAND'S STANDARD CONNECTOR DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103714 ↗
• MalfunctionNov 9, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WOULD POP OFF WITHOUT ANYONE TOUCHING IT DURING USE WITH AN OTHER BRAND'S STANDARD CONNECTOR, AND SOMETIMES IT COULD NOT FIT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18103521 ↗
• MalfunctionJun 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS PIERCED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242783 ↗
• MalfunctionJun 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBES "RUPTURED" FOUR TIMES. IT WAS ALSO STATED THAT OTHER TUBES ONLY HOLD PRESSURE FOR 15 MINUTES AND THEN LOSE AIR WHICH THE REPORTER THOUGHT TO BE RELATED TO THE PILOT SPRING. A HOLE WAS ALSO FOUND ON THE FAILED CUFF. REPLACEMENT OF THE TUBE WAS DONE. ONE DEVICE WAS RETURNED WITH NO FAILURE REPORTED BUT MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT AIR LEAKED RAPIDLY FROM THE MAIN BODY OF THE CUFF AND THERE IS A CLEAN CUT SLIT IN THE MAIN BODY OF THE CUFF MEASURING 1.3MM IN LENGTH.

  Patient problems: Insufficient Information

  MAUDE report 17241340 ↗
• MalfunctionMay 30, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBE "RUPTURED" WHILE IN USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17018645 ↗
• MalfunctionMay 12, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HOLDS PRESSURE FOR FIVE MINUTES THEN SLOWLY LOSES AIR DURING USE. THE TUBE WAS REPLACED AND THE PATIENT WAS STABLE.

  Patient problems: Unintended Extubation

  MAUDE report 16919566 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBES "RUPTURED" FOUR TIMES. IT WAS ALSO STATED THAT OTHER TUBES ONLY HOLD PRESSURE FOR 15 MINUTES AND THEN LOSE AIR WHICH THE REPORTER THOUGHT TO BE RELATED TO THE PILOT SPRING. A HOLE WAS ALSO FOUND ON THE FAILED CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16906452 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBES "RUPTURED" FOUR TIMES. IT WAS ALSO STATED THAT OTHER TUBES ONLY HOLD PRESSURE FOR 15 MINUTES AND THEN LOSE AIR WHICH THE REPORTER THOUGHT TO BE RELATED TO THE PILOT SPRING. A HOLE WAS ALSO FOUND ON THE FAILED CUFF. REPLACEMENT OF THE TUBE WAS DONE. ONE DEVICE WAS RETURNED WITH NO FAILURE REPORTED BUT MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT AIR LEAKED RAPIDLY FROM THE MAIN BODY OF THE CUFF AND THERE IS A CLEAN CUT SLIT IN THE MAIN BODY OF THE CUFF MEASURING 1.3MM IN LENGTH.

  Patient problems: Unintended Extubation

  MAUDE report 16905026 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBES "RUPTURED" FOUR TIMES. IT WAS ALSO STATED THAT OTHER TUBES ONLY HOLD PRESSURE FOR 15 MINUTES AND THEN LOSE AIR WHICH THE REPORTER THOUGHT TO BE RELATED TO THE PILOT SPRING. A HOLE WAS ALSO FOUND ON THE FAILED CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16905019 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH TUBES "RUPTURED" FOUR TIMES. IT WAS ALSO STATED THAT OTHER TUBES ONLY HOLD PRESSURE FOR 15 MINUTES AND THEN LOSE AIR WHICH THE REPORTER THOUGHT TO BE RELATED TO THE PILOT SPRING. A HOLE WAS ALSO FOUND ON THE FAILED CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16905006 ↗
• MalfunctionJan 6, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A TRACHEOSTOMY PROCEDURE, THE DEVICES WERE OPENED IN STERILE FIELD AND CUFFS WERE INFLATED/DEFLATED WHEN TESTED IN A BASIN OF SALINE WITH AIR. AFTER PLACING THE DEVICE, THE CUFFS WERE NOT HOLDING ADEQUATE AIR. A HOLE WAS OBSERVED IN THE CUFF. THE TUBE HAS BEEN REMOVED AND REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16112677 ↗
• MalfunctionDec 13, 2022Gas/Air Leak; Insufficient Device Problem Information; Gas/Air Leak; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, A NEW TRACH TUBE WAS OPENED AND THE BALLOON WAS TESTED TO REPLACE A DEFECTIVE TRACH. WHEN THE NEW TRACH WAS PLACED AND DRAPES WERE REMOVED FROM PATIENT, THE NEW TRACH TUBE WAS AGAIN NOT HOLDING AIR. REMOVED AND REPLACED WITH DIFFERENT TRACH TYPE/BRAND. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15971099 ↗
• MalfunctionDec 12, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE TRACHEOSTOMY PROCEDURE, TRACH WAS OPENED AND BALLOON WAS TESTED. AFTER PLACING THE TRACH, THE BALLOON WAS NOT HOLDING ADEQUATE AIR, IT WAS REMOVED AND REPLACED. THERE WAS NO PATIENT PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15959998 ↗
• MalfunctionDec 1, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A  TRACHEOSTOMY PROCEDURE, THE DEVICE WAS OPENED IN STERILE FIELD AND BALOON WAS TESTED. AFTER PLACING THE DEVICE, THE BALLOON WAS NOT HOLDING ADEQUATE AIR IN THE BALLOON. IT WAS REMOVED AND REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 15897128 ↗
• MalfunctionDec 10, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PILOT BALLOON HAD A INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975464 ↗
• MalfunctionNov 7, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A BEDSIDE TRACHEOSTOMY WAS PERFORMED WITH AN 8.0 CUFFED TRACH TUBE WHEN A CUFF LEAK WAS FOUND. TROUBLESHOOT WITH NO SUCCESS SO THE TUBE WAS REMOVED AND THE PATIENT WAS TAKEN TO OR FOR A PROCEDURE. THE TUBE WAS INSPECTED AND NOTED THE LEAK AT THE CUFF'S PILOT LINE.

  Patient problems: Unintended Extubation

  MAUDE report 12759085 ↗
• InjurySep 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A DAY AFTER THE REPLACEMENT, THE PATIENT DEVELOPED BLEEDING ON THE SITE OF THE TUBE AND RETURNED TO THE OR FOR THE REVISION OF THE TRACHEOSTOMY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12513416 ↗